The Recall Desk

Hazard

Leakage recalls

152 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all leakage recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–25 of 152

  • HighFDA (Devices)·Z-2203-2026·2026-05-27

    Swan-Ganz Jr Catheter models recalled due to lumen hub leakage

    Becton, Dickinson and Company is recalling Swan-Ganz Jr Catheters (models SGPT54, SGPT64P, SGPT755P) because the blue proximal injectate lumen hub may leak or break due to manufacturing changes, risking infection, medication loss, and blood loss.

    Product
    Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0496-2026·2026-04-29

    Dextrose Injection USP recalled due to sterility assurance concerns

    B. Braun Medical Inc. is recalling Dextrose Injection USP 70% in 2000 mL bags nationwide due to lack of assurance of sterility and potential leakage from the diaphragm port after foil removal.

    Product
    DEXTROSE — DEXTROSE (DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0497-2026·2026-04-29

    Sodium Chloride for Irrigation Lacks Sterility Assurance

    B. Braun Medical Inc. is recalling sodium chloride for irrigation solution (3000 mL bags) due to lack of assurance of sterility and potential leakage from the diaphragm port. Affected lots distributed nationwide have expiration dates through May 31, 2028.

    Product
    SODIUM CHLORIDE FOR IRRIGATION — SODIUM CHLORIDE FOR IRRIGATION (SODIUM CHLORIDE FOR IRRIGATION)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1690-2026·2026-04-08

    Medline ENFIT G-Tube Connector Recalled for Defective Seal Formation Risk

    Medline is recalling 651,789 ENFIT G-Tube Connectors because they may not form a proper seal with compatible feeding devices, risking leakage that could delay care and cause fluid loss.

    Product
    ENFIT G-TUBE CONNECTOR, MEDLINE Item No. ENFIT1010GC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1691-2026·2026-04-08

    Medline ENFIT G-Tube Connector Kits Recalled for Seal Defects

    Medline recalls 9,040 ENFIT G-tube connector kits due to manufacturing defects preventing proper sealing and causing leakage, risking delayed care. Over-tightening to prevent leakage risks infection and additional clinical complications.

    Product
    Medline Kits containing ENFIT G-TUBE CONNECTOR 1. SKU DYKM2720 G/J TUBE CARE KIT 2. SKU ENFITDISCKIT ENFIT DISCHARGE KIT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1583-2026·2026-03-25

    ConvaTec EsteemBody Drainable Pouch recalled due to manufacturing defect

    ConvaTec is recalling EsteemBody Drainable Pouch (10-35mm, Lot 5K01728) because a manufacturing issue may cause the pouch to leak. No illnesses or injuries have been reported.

    Product
    Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1088-2026·2026-01-21

    Medline Surgical Procedure Kits Recalled Due to Irrigation Solution Leakage

    Medline is recalling 12,584 surgical procedure kits containing Stryker Strykeflow 2 irrigators due to a design defect that causes irrigation solution to leak and emit vaporized saline during use.

    Product
    Medline medical procedure convenience kits labeled as: 1) ROBOTIC, REF CDS980523M; 2) ROBOTIC GYN, REF CDS980647K; 3) DAVINCI PROCEDURE, REF CDS980864Q; 4) GYN-URO LAPSCP CDS-LF, REF CDS981583U; 5) GYN-URO LAPSCP CDS-LF, REF CDS981583V; 6) GYN ROBOTIC, REF CDS981826K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1101-2026·2026-01-21

    Portex Spinal Tray syringes recalled due to syringe collar cracks

    ICU Medical is recalling Portex Spinal Tray syringes due to cracks in the syringe collar. The defect may cause delayed blood draws, fluid leakage during arterial blood sampling, or improper delivery.

    Product
    Portex Spinal Tray, Item No. A3729-24 A3595
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1090-2026·2026-01-21

    Medline Stryker robotics urology kits recalled for irrigation fluid leakage risk

    Medline is recalling robotics urology procedure kits with Stryker Strykeflow 2 Suction Irrigators due to a 2024 design change that allows irrigation solution to leak and emit vaporized saline during use.

    Product
    Medline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY PROSTATE, REF DYKMBNDL116G
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0198-2026·2025-12-10

    Testosterone Gel 1% Recalled Due to Defective Container Side-Seal Allowing Leakage

    Teva Pharmaceuticals recalls Testosterone Gel 1% due to a defect in the container side-seal that allows product leakage. The recall affects lot #100068692 (expiration 04/30/2027) consisting of approximately 15,944 cartons distributed nationwide.

    Product
    TESTOSTERONE — TESTOSTERONE (TESTOSTERONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0569-2026·2025-11-26

    Meridian Bioscience Streptococcus Test Kits Recalled for Missing Buffer Gasket

    Meridian Bioscience recalled 109 units of its Group B Streptococcus test assay because the reaction buffer tube cap may be missing the black rubber gasket. This defect could cause leakage and reduce buffer volume.

    Product
    Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Acid Amplification Test Assay
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0365-2026·2025-11-05

    ChemosafeLock Vial Adapter port weld may separate and cause drug leakage

    ICU Medical is recalling ChemosafeLock Vial Adapters due to a port weld defect that may separate or break during use, potentially causing drug leakage. Approximately 202,900 units are affected worldwide.

    Product
    ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0342-2026·2025-11-05

    ICU Medical ChemoLock Port Syringe Transfer Set Weld May Separate

    ICU Medical is recalling certain ChemoLock Port Syringe Transfer Sets because the port weld may separate or break during use, potentially causing drug leakage. The recall affects 4,000 units distributed nationwide and internationally.

    Product
    ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0348-2026·2025-11-05

    ICU Medical ChemoLock Closed Vial Spike Weld May Separate During Use

    A weld defect in the ICU Medical ChemoLock Closed Vial Spike may cause the device to separate or leak during use in healthcare drug transfer applications. The recall affects 8,475 units distributed in the US and internationally.

    Product
    ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0358-2026·2025-11-05

    ICU Medical Extension Set Port Weld May Separate During Use

    ICU Medical extension sets may experience weld separation, potentially leaking medication. The FDA has issued a Class II recall for 2,450 units distributed nationwide and internationally.

    Product
    ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0359-2026·2025-11-05

    IV Drug Transfer Device Port Weld May Fail and Cause Leakage

    ICU Medical is recalling approximately 11,000 IV drug transfer devices due to a potential weld defect. The port weld may separate or break during use, potentially resulting in a leak.

    Product
    ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Cap, Hanger REF: CL3951
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0353-2026·2025-11-05

    ICU Medical bag spike port weld may separate or break

    A weld on ICU Medical bag spike components may separate during use, potentially causing drug leakage.

    Product
    ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0199-2026·2025-10-22

    FDA Recalls Baxter IV Extension Sets Due to Potential Leakage

    Baxter Healthcare recalls 16,416 CLEARLINK System Extension Sets due to potential leakage. The nationwide recall affects IV extension sets that may not function properly during use.

    Product
    CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 7.9-inch (20 centimeters), Product Code 2C8634
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0203-2026·2025-10-22

    Medical Device IV Infusion Sets Recalled for Potential Leakage

    Baxter Healthcare Corporation recalls CLEARLINK paclitaxel IV infusion sets that may leak during use. The 27,072 affected units were distributed nationwide; patients should contact their healthcare provider.

    Product
    CLEARLINK System Paclitaxel Set, Non-Vented with Polyethylene Lined Tubing and CLEARLINK Luer Activated Valve, 0.2 Micron Filter, CLEARLINK Luer Activated Valve, 10 drops/mL, 107-inch (2.7 meters), Product Code 2R8858
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0195-2026·2025-10-22

    Medical Device: CLEARLINK CONTINU-FLO Solution Sets Recalled for Potential Leaks

    Baxter Healthcare is recalling CLEARLINK CONTINU-FLO IV solution sets (Product Code 2C8571, Lot R25B24055) due to potential leakage. Approximately 106,176 units were distributed nationwide.

    Product
    CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 104-inch (2.6 meters), Product Code 2C8571
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0193-2026·2025-10-22

    IV Solution Set Recalled Due to Potential Leaks

    Baxter Healthcare is recalling 958,351 CLEARLINK SYSTEM CONTINU-FLO IV solution sets nationwide due to potential leaks. The voluntary recall affects units distributed to all 50 states.

    Product
    CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops/mL, 120-inch (3.0 meters), Product Code 2C8537
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0201-2026·2025-10-22

    IV Solution Sets Recalled for Potential Leakage Risk Nationwide

    Baxter Healthcare has recalled approximately 48,000 CLEARLINK SYSTEM CONTINU-FLO IV solution sets nationwide due to potential leakage. The voluntary recall affects lot R25C26116 distributed across all U.S. states.

    Product
    CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves. 10 drops/mL, 96-inch (2.4 meters). Non-DEHP, Product Code 2R8519
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1970-2025·2025-06-18

    BD Alaris Infusion Sets May Leak, Risking Hazardous Drug Exposure

    BD infusion sets may leak at the luer connector, potentially exposing patients to hazardous drugs or causing medication underdosing. Multiple product types are affected.

    Product
    Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium With Priming Cap Back Check Valve 2 SmartSite Y-Sites, REF: 10013361T; SmartSite Bag Access Non-Vented Bonded Texium Closed Male Luer With Priming Cap, REF: 10321213T; SmartSite Bag Access Non-Vented Low
    Category
    Medical Device
    Distribution
    Distributed nationwide